BRIEF—FDA approves Sorilux for adolescent plaque psoriasis

The US Food and Drug Administration has approved Sorilux (calcipotriene) Foam, 0.005% in adolescents, from Australia-based Mayne Pharma.

Sorilux, which, along with other on-market dermatology foam assets, was acquired from UK pharma major GlaxoSmithKline in 2016 for $50.1 million, is now approved for treating plaque psoriasis of the scalp and body in patients aged 12 years and older.

The FDA approved Sorilux in 2010 based on evidence from two 8-week placebo controlled clinical trials in patients with mild to moderate plaque psoriasis of the body and one 8-week placebo controlled clinical trial in patients with moderate plaque psoriasis of the scalp. Further data was obtained in a follow-on open label study in patients aged 12 to 17 years of age with psoriasis.

Sorilux Foam contains calcipotriene, a synthetic vitamin D analog that has a similar receptor binding affinity as natural vitamin D. The exact mechanism of action contributing to the clinical efficacy is unknown.